(Utkast) Kommisjonens gjennomføringsbeslutning (EU) .../... om, innenfor rammen av artikkel 107e i europaparlaments- og rådsdirektiv 2001/83/EF, markedsføringstillatelser av legemidler til mennesker som inneholder det aktive stoffet "spironolakton"
Legemiddeldirektivet: markedsføringstillatelser for produkter inneholdende spironolakton
(Draft) Commission Implementing Decision (EU) .../... concerning, in the framework of Article 107e of Directive 2001/83/EC of the European Parliament and of the Council, the marketing authorisations of medicinal products for human use which contain the active substance "spironolactone"
Utkast til kommisjonsbeslutning godkjent av komite (representanter for medlemslandene) og publisert i EUs komitologiregister 10.3.2025
Bakgrunn
(fra kommisjonsbeslutningen)
(1) Medicinal products for human use authorised by the Member States must meet the requirements of Directive 2001/83/EC.
(2) Periodic safety update reports concerning medicinal products containing the same active substance were submitted. The reports were assessed by the Pharmacovigilance Risk Assessment Committee as to whether the marketing authorisations concerned should be maintained, varied, suspended or withdrawn.
(3) The scientific assessment performed by the Committee for Medicinal Products for Human Use, the conclusions of which are set out in Annex I to this Decision, shows that a decision should be taken amending the marketing authorisations for the medicinal products concerned.
(4) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Medicinal Products for Human Use,